Background and importance Tacrolimus is an immunosuppressant with many potential uses in ophthalmic diseases. It is an inhibitor of calcineurin phosphatases, which suppress the first phase of T cell activation and leads to a decrease in inflammatory activity. There are no commercialised eye drops in Spain so its formulation as a pharmaceutical compound has to be done by the hospital pharmacy services.
Aim and objectives To evaluate the use, tolerance and adherence of 0.03% tacrolimus eye drops as a pharmaceutical compound.
Material and methods A retrospective observational study was conducted in patients treated with 0.03% tacrolimus eye drops from January 2017 to March 2020. The eye drops were prepared and dispensed by the hospital pharmacy service. For the preparation, 0.6 mL of intravenous Prograf 5 mg/mL were diluted with Liquifilm to a final volume of 10 mL.
Demographic (sex and age) and clinical data (diagnosis, duration, adherence and tolerance) were recorded using electronic prescription and electronic medical records. Adherence was measured using registered dispensations as well as by follow-up controls by an ophthalmologist. We classified as the most compliant patients those with no delay in dispensation times in the pharmacist consultation.
Results 54 patients (57% men) with a mean age of 32±21 years used tacrolimus eye drops during the study period. Tacrolimus eye drops were used for the treatment of immune mediated ophthalmic inflammatory diseases in 61.8% of patients, of whom 49.1% were for atopic or vernal keratoconjunctivitis. 20.0% of the total number of patients used the eye drops for hyperaemia of unknown cause,12.7% were used for dry eye and the remaining 5.4% for the treatment of graft rejections.
Mean duration of treatment was 1.8±1.0 years. Tolerance was generally good. Only 24.07% of patients presented with itching, and 2 patients (3.70%) had palpebral dermatitis and miosis. 50% of patients were highly compliant (having no delay in dispensations), 38.89% had delayed dispensing at least once, 9.26% had delayed dispensing at least twice and 1.85% had irregular dispensations.
Conclusion and relevance 0.03% tacrolimus eye drops were used primarily for the treatment of vernal or atopic keratoconjunctivitis but they have wide potential uses in ophthalmology diseases. The formulation was well tolerated by most of patients and adherence was generally correct, as measured by the pharmacist consultations.
Conflict of interest No conflict of interest
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